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Trial registered on ANZCTR


Registration number
ACTRN12614000946617
Ethics application status
Approved
Date submitted
17/08/2014
Date registered
4/09/2014
Date last updated
4/09/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Kunzea oil for the management of fungal nail infection (toenail onychomycosis), a pilot randomised controlled trial.
Scientific title
Evaluation of kunzea oil for the management of toenail onychomycosis with amorolfine lacquer, a pilot randomised, controlled trial.
Secondary ID [1] 285183 0
PRJ-000464
Universal Trial Number (UTN)
NIL
Trial acronym
NIL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
fungal nail infection (toenail onychomycosis) 292781 0
Condition category
Condition code
Skin 293078 293078 0 0
Dermatological conditions
Alternative and Complementary Medicine 293214 293214 0 0
Other alternative and complementary medicine
Infection 293215 293215 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group A [test] received topical test treatment with kunzea oil (twice daily), and group B [control] applied control medication, amorolfine lacquer (weekly) for 40+/-2 weeks.


Neat kunzea oil (100%; steam distilled and commercially produced in Tasmania from the bush plant Kunzea ambigua), patients were given instructions to apply the oil twice daily (morning and evening) for 40+/- 2 weeks.


Compliance:Furthermore, compliance to the treatment protocol was encouraged by bi-monthly telephone calls and letters. Furthermore, the research assistant reminded the subjects of the importance of adhering to the treatment protocol at each of their follow-up visits to the podiatry clinic.
Intervention code [1] 290044 0
Treatment: Drugs
Comparator / control treatment
Patients were given instructions to apply the Loceryl Nail Lacquer (containing 5% amorolfine), once weekly following nail filing for 40+/- 2 weeks.
Control group
Active

Outcomes
Primary outcome [1] 292941 0
Primary efficacy variable was mycological cure (negative mycology) at week 40'+/-'2 weeks.

The primary outcome was assessed by culturing the nail clippings (by following the standard microbiology procedure at Royal Hobart Hospital) collected from patients' target toenails before commencing the therapy and after 40'+/-'2 weeks.
Timepoint [1] 292941 0
Time-point: at baseline and 40'+/-' 2 weeks after randomisation
Secondary outcome [1] 309981 0
Clinical severity score.

Clinical signs were graded on a visual analogue scale (0– 4).
This was based on a Visual analogue scale (VAS) previously used in a clinical trial as a secondary outcome. The VAS used is a 10 cm long straight line, marked at each end with labels which anchor the scale.



Reference: Rigopoulos D, Katoulis A, Ioannides D, et al. A randomized trial of amorolfine 5% solution nail lacquer in association with itraconazole pulse therapy compared with itraconazole alone in the treatment of Candida fingernail onychomycosis. British Journal of Dermatology 2003;149:151-156.
Timepoint [1] 309981 0
at week 40'+/-' 2weeks
Secondary outcome [2] 310084 0
Changes in healthy nail (clear) area.

The unaffected (clear) toenail area was measured using standardised digital photographs, because not all of the tracings included the clear nail area.


Timepoint [2] 310084 0
assessment at 40'+/-' 2 weeks
Secondary outcome [3] 310085 0
changes in symptomatic nail (diseased) area

An adhesive sterile transparent film (OpSite Flexifix) was placed over the infected nail surface and the perimeter was traced. The areas of the tracings were determined by the cut-and-weigh technique.

References:

Thomas J, Narkowicz C, Peterson G, Jacobson G, Narayana A. Randomised controlled trial of the treatment of pastern dermatitis with a formulation containing kunzea oil. Veterinary Record 2009;164:619-623.

Whited JD, Hall RP, Simel DL, et al. Reliability and accuracy of dermatologists' clinic-based and digital image consultations. Journal of the American Academy of Dermatology 1999;41:693-702.

Nayler JR. Clinical photography: a guide for the clinician. Journal of postgraduate medicine 2003;49:256-62.
Timepoint [3] 310085 0
at 40 '+/-' 2 weeks

Eligibility
Key inclusion criteria
Entry criteria required a clinical diagnosis of onychomycosis (based on clinical manifestations and positive mycology [mycological culture]) involving less than or equal to 20% of the area of one of the great toenails and a minimum age of 18
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The main exclusion criteria were other nail conditions (psoriasis, bacterial infections, contact dermatitis, nail bed tumours, yellow nail syndrome, traumatic onychodystrophies, lichen planus, pachonychia congenita and idiopathic onycholysis ) confounding onychomycosis assessment, pregnancy, breast-feeding, and a known history of allergy to essential oils. All patients had a 6-week washout period for systemic antifungal therapy and 4 weeks for topical antifungal treatment prior to receiving the study drugs

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients with onychomycosis who were willing to comply with the requirements of the protocol were recruited into the study following a local newspaper advertisement. Of the 130 subjects who gave consent and provided a nail specimen for mycological screening, 93 subjects had mycological confirmation of onychomycosis and were randomly assigned to the trial medications.
Test formulations were prepared in the compounding pharmaceutical laboratory in the School of Pharmacy, University of Tasmania, under the supervision of a registered pharmacist. The control formulations (Loceryl 'Registered Trademark') were obtained from the commercial supplier (Galderma Pty Ltd, Belrose, NSW, Australia). The study medications were packed in identical containers and the code was kept secure by a staff member (based at University of Tasmania) who was not part of the research team. When patients entered into the trial (after eligibility assessment and wash-out period), the clinical investigator’s office contacted the university staff to send the medications (via express registered post) directly to the patients. The same method was followed for the additional supply of medications to study subjects. This enabled the clinical investigator (performing assessments) and other study personnel to be blinded throughout the study period.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Once informed written consent had been obtained, the inclusion/exclusion criteria and baseline assessments have been satisfied /completed, the participants were randomly allocated into one of two groups (test or control) using a computer-generated randomisation schedule.

Randomisation was provided by the study Sponsor, using an independent statistician.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Randomised, controlled
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
TAS
Recruitment hospital [1] 2885 0
Royal Hobart Hospital - Hobart
Recruitment postcode(s) [1] 8577 0
7001 - Hobart

Funding & Sponsors
Funding source category [1] 289792 0
Government body
Name [1] 289792 0
Rural Industrial Development Corporation
Address [1] 289792 0
Level 2, 15 National Circuit, Barton ACT 2600
Country [1] 289792 0
New Zealand
Primary sponsor type
University
Name
University of Tasmania
Address
Churchill Avenue, Sandy Bay, Hobart TAS 7005
Country
Australia
Secondary sponsor category [1] 288483 0
None
Name [1] 288483 0
Address [1] 288483 0
Country [1] 288483 0
Other collaborator category [1] 278099 0
Hospital
Name [1] 278099 0
Royal Hobart Hospital, Tasmania
Address [1] 278099 0
48 Liverpool St, Hobart TAS 7000
Country [1] 278099 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291528 0
Human Research Ethics Committee Tasmania Network
Ethics committee address [1] 291528 0
Private Bag 01, Hobart, Tasmania 7001, Australia
Ethics committee country [1] 291528 0
Australia
Date submitted for ethics approval [1] 291528 0
Approval date [1] 291528 0
16/11/2006
Ethics approval number [1] 291528 0
H0008560

Summary
Brief summary
Onychomycosis is a common nail infection. Current topical therapies are largely ineffective, systemic drugs have significant safety risks, and are limited in broader range of patients. A safe, relatively inexpensive, alternative topical treatment is required to minimise treatment failures and relapses, and also as an adjuvant treatment to improve cure rates. The present study compared the efficacy and safety of topical kunzea oil (twice daily) with amorolfine (once weekly) for the management onychomycosis (study duration 40' +/-' 2 weeks). The study recruited patients from single site (Royal Hobart Podiatry).
Trial website
NIL
Trial related presentations / publications
Conferences

*Thomas J, Narkowicz, CK, Peterson, GM, Jacobson, GA, Burnet, H & Ceridwen C, ‘A randomised trial of kunzea oil in comparison with amorolfine 5% solution nail lacquer for the treatment of toenail onychomycosis in adults, Sharing Excellence in Research Conference’, UTAS annual postgraduate research conference (2008)

*Thomas J, Narkowicz, CK, Peterson, GM, Jacobson, GA, Burnet, H & Ceridwen C, ‘A randomised trial of Kunzea oil in comparison the treatment of toenail onychomycosis’, Proceedings of the APSA Annual Conference, Hobart, (2009)

*Sharpe, CE and Lennox, S, Burnet, H & Thomas, J, Royal Hobart Hospital Podiatry Department involvement in collaborative research with University of Tasmania, School of Pharmacy: 'A pilot randomised trial of Tasmanian oil in comparison with amorolfine nail lacquer for the treatment of toenail onychomycosis', Public sector podiatry Conference, 12-13 June 2008, Adelaide, South Australia, pp. 14.


Publications

*Jacobson G. A, C. Narkowicz, J. Thomas & Peterson G. M (2009) Clinical trial of kunzea oil for onychomycosis treatment, Rural Industries Research & Development Corporation.

*Thomas J, Jacobson, G. A, Narkowicz, C, Peterson, G. M, Burnet H, & Ceridwen, S (2010) Toenail onychomycosis an important global disease burden-A review, Journal of Clinical Pharmacy and Therapeutics, 35(5) 497-519.

Public notes
NIl

Contacts
Principal investigator
Name 50750 0
Dr Jackson Thomas
Address 50750 0
University of Canberra
Faculty of Health, University of Canberra
Kirrinari Street, ACT 2601
Country 50750 0
Australia
Phone 50750 0
+61 (0)2 62068928
Fax 50750 0
+61 (0)2 6201 5727
Email 50750 0
Jackson.Thomas@canberra.edu.au
Contact person for public queries
Name 50751 0
Dr Jackson Thomas
Address 50751 0
University of Canberra
Faculty of Health, University of Canberra
Kirrinari Street, ACT 2601
Country 50751 0
Australia
Phone 50751 0
+61 (0)2 62068928
Fax 50751 0
+61 (0)2 6201 5727
Email 50751 0
Jackson.Thomas@canberra.edu.au
Contact person for scientific queries
Name 50752 0
Dr Jackson Thomas
Address 50752 0
University of Canberra
Faculty of Health, University of Canberra
Kirrinari Street, ACT 2601
Country 50752 0
Australia
Phone 50752 0
+61 (0)2 62068928
Fax 50752 0
+61 (0)2 6201 5727
Email 50752 0
Jackson.Thomas@canberra.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary